drugset / Trial / NCT01895023

Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children

NCT01895023 ↗

Phase 4 Completed 156 enrolled Yao Yusheng West China Hospital · collab
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid onset and offset of action.The reported incidence of emergence agitation (EA) following sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA is still considered as a potentially serious complication because of the risks of self-injury, and because of the stress caused to both caregivers and families. Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic actions, has been used in pediatric populations.Several prospective clinical trials in children have shown that dexmedetomidine significantly reduces the incidence of EA prior to recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication on emergence agitation has not been fully evaluated. The purpose of the present study was to verify the hypothesis that intranasal premedication with dexmedetomidine is effective in reducing emergence agitation after sevoflurane anaesthesia.

Timeline

Start
2013-09
Primary completion
2014-08
Completion
2014-08

Outcome

Met primary endpoint

paper The incidence of emergence delirium was lower in patients given dexmedetomidine compared with that in patients given midazolam (11.5 versus 44% PMID 32976205 ↗

paper or 0.9% saline (11.5 versus 49%, relative risk = 0.235, 95% confidence interval 0.105 to 0.525). PMID 32976205 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 2 ug/kg Intranasal
Comparator Midazolam Small molecule 0.5 mg/kg Oral

Indications